Expandable Intravascular Blood Pump for High Flow in Small Access
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Solution Overview
Problem
Current percutaneously-inserted ventricular assist devices (pVADs) are undesirably large, cause significant hemolysis, and require large vascular access, leading to complications and insufficient blood flow, necessitating improvements for minimally invasive insertion and enhanced blood flow capabilities.
Innovation Solution
Intravascular blood pumps with an expandable member and impeller system, featuring a conduit radially disposed within the expandable member, allowing for a smaller delivery profile and improved blood flow rates, while minimizing hemolysis and thrombosis, and capable of deployment across cardiac valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current pVADs are designed to provide sufficient blood flow (3.5 to 6.0 L/min), then blood flow capability is improved, but device size increases requiring large vascular access (greater than 12 FR)
Solution Approach 1:
The conduit is nested radially inside the expandable member, allowing the blood flow lumen to be contained within the device structure. This nested configuration enables sufficient blood flow (3.5 to 6.0 L/min) while maintaining a compact delivery profile that can be inserted through smaller vascular access (less than 12 FR, such as 8 FR or 9 FR).
Solution Approach 2:
The expandable member can be collapsed to a small delivery profile for insertion through small vascular access, then expanded to a larger operational profile to provide sufficient blood flow (3.5 to 6.0 L/min). This dynamic transformation allows the device to transition from a compact delivery state to a high-flow operational state, resolving the contradiction between device size and blood flow capability.
2Productivity
If higher rotary pump impeller speeds are used to increase blood flow, then productivity is improved, but hemolysis risk increases
Solution Approach 1:
The device achieves sufficient blood flow (3.5 to 6.0 L/min) at significantly lower rotational speeds than conventional pVADs (less than 50,000 rpm). By changing the operational parameters to use lower speeds, the system maintains high productivity while reducing hemolysis risk. The conduit design also optimizes flow characteristics to achieve adequate blood flow without requiring excessive impeller speeds.
3Ease of operation
If larger access sheaths are used to accommodate current pVADs, then device insertion is facilitated, but procedure complications increase
Solution Approach 1:
The expandable member can be collapsed to a small delivery profile that fits through small vascular access (less than 12 FR, such as 8 FR or 9 FR), enabling minimally invasive insertion. This dynamic collapse capability facilitates easier procedure insertion while reducing complications associated with large access sheaths, maintaining reliability without sacrificing ease of operation.
4Productivity
If conventional pVADs are used to provide blood flow support, then circulatory function is improved, but hemolysis and thrombosis increase
Solution Approach 1:
The device operates at significantly lower rotational speeds than conventional pVADs, reducing the mechanical stress on blood cells and minimizing hemolysis. The conduit design with radial positioning inside the expandable member optimizes flow patterns to reduce turbulence and thrombosis risk, thereby providing blood flow support while generating fewer harmful effects.
Solution Approach 2:
The conduit nested radially inside the expandable member creates a streamlined flow path that reduces turbulence and contact between blood and device surfaces. This nested configuration minimizes hemolysis and thrombosis while maintaining effective blood flow (3.5 to 6.0 L/min), addressing the harmful effects generated by conventional designs.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution provides a smaller, minimally invasive blood pump that achieves 3.5 to 6.0 L/min blood flow with reduced hemolysis and thrombosis, facilitating safer procedures and improved patient outcomes.
Implementation Method 1
an impeller disposed radially and axially within the expandable member
Implementation Method 2
an expandable member having a collapsed, delivery configuration and an expanded, deployed configuration
Data Source
Figure 1A~1E
Figure 2A~2B
Figure 3A~3B
AI summary
An intravascular fluid movement device that includes an expandable member having a collapsed, delivery configuration and an expanded, deployed configuration, the expandable member having a proximal end and a distal end, a rotatable member disposed radially and axially within the expandable member, and a conduit coupled to the expandable member, the conduit at least partially defining a blood flow lumen between a distal end of the conduit and a proximal end of the conduit, the conduit disposed solely radially inside of the expandable member in a distal section of the expandable member.